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Prospective Evaluation of Intrafractional and Interfractional Cervical Motion During External Beam Radiation for Intact Cervical Cancer by the Calypso® 4D Localization System™

This study has been withdrawn prior to enrollment.
(

Study closed by IRB because a Continuing Review and/or Close-Out have not been submitted.

Study closed by IRB

)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907634
First Posted: May 22, 2009
Last Update Posted: October 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter J. Rossi, MD, Emory University
  Purpose

The purpose of this study is to find out how the cervix normally moves during radiation treatment. This study will also evaluate how cervical cancer shrinks during chemotherapy and radiation. By better understanding these two things, the investigators can see if radiation could safely be given in a more focused way in the future.

The investigational portion of this study includes (1) daily cone beam CT scans to confirm transponder placement and evaluate tumor changes during treatment and (2) tracking movement of the cervix during daily radiation treatment.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Evaluation of Intrafractional and Interfractional Cervical Motion During External Beam Radiation for Intact Cervical Cancer by the Calypso® 4D Localization System™

Resource links provided by NLM:


Further study details as provided by Peter J. Rossi, MD, Emory University:

Enrollment: 0
Study Start Date: February 2009
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage IB-IV Cervical cancer patients
Criteria

Inclusion Criteria:

  • Stage IB-IVA Cervical Squamous cell carcinoma
  • Karnofsky Performance Score 60-100

Exclusion Criteria:

  • Other histologies
  • Karnofsky Performance Score < 60
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907634


Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Peter Rossi, MD Emory University
  More Information

Responsible Party: Peter J. Rossi, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00907634     History of Changes
Other Study ID Numbers: IRB00013078
EmoryCervicalMotion ( Other Identifier: Other )
First Submitted: May 21, 2009
First Posted: May 22, 2009
Last Update Posted: October 24, 2013
Last Verified: October 2013

Keywords provided by Peter J. Rossi, MD, Emory University:
cervix
cervical
radiation

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female